Sealed Therapeutic Shoe as Treatment of Diabetic Foot Ulcers

Diabetic Foot Clinical Trial

Official title:

Sealed Therapeutic Shoe vs. Total Contact Cast as Treatment of Diabetic Foot Ulcers: a Multicenter RCT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04085926
• Other study ID #: 18RS6667
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2019
• Est. completion date: December 2027

Study information

• Verified date: September 2019
• Source: Region Örebro County
• Contact: Gustav Jarl, PhD
• Phone: +46-19-6025875
• Email: gustav.jarl[@]regionorebrolan.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Total contact casts (TCCs) are effective treatment of plantar diabetic foot ulcers because they effectively offload the ulcer and are non-removable, resulting in high adherence to using the device. However, TCCs are not widely used in clinical practice because they negatively impact gait and daily activities. A new treatment concept was invented, sealed therapeutic shoe, where a shoe with a custom-made insole offloads the ulcer, and the shoe is rendered irremovable to be worn day and night, like a TCC.

In this multicenter randomized controlled trial (RCT), 150 participants will be recruited and randomized to two treatment arms: TCC or sealed therapeutic shoe. The primary outcome is ulcer healing, secondary outcomes include (but are not limited to) skin complications, glycemic control, body mass index, gait function, balance, quality of life, physical activity, and health economics.

Description:

Data for the primary outcome of 112 participants are needed but the aim is to recruit 150, if possible within a reasonable time frame, to take drop-out into account.

Participants are randomized (blocked randomization, stratified for ulcer site and study center) to either treatment with a sealed therapeutic shoe or total contact cast.

Each participant will be assessed by a cast technician during the treatment period (for ulcer healing and skin complications) and be assessed by a physiotherapist on five occasions: at baseline, approximately 4 weeks into treatment and 1, 6 and 12 months after treatment end. On these occasions the physiotherapist will perform different tests (gait, balance, ankle strength and flexibility, bone mass density in heel bone, etc) and participants will answer questionnaires and have their physical activity measured for 7 days with an activity monitor.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2027
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with diabetes mellitus (any kind)

• Foot ulcer under metatarsal heads

Exclusion Criteria:

• large ulcer (3-5 metatarsal heads)

• critical ischemia (defined as toe pressure <30 mmHg or TcPO2 <30 mmHg)

• uncontrolled infection (IWGDF infection grade 4, or grade 3 if not treatment against infection has been administered)

• Active Charcot foot

• foot deformities that necessitate custom-made shoes

• inability to speak/read Swedish.

• People with increased risk that side-effects will not be discovered or reported (dementia, abuse of alcohol or drugs, intellectual disability, etc.) if the person do not have appropriate social support, will be excluded.

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer

Intervention

Device:
• Sealed therapeutic shoe
Off-the-shelf therapeutic shoe and custom-made insole
• Total contact cast
Custom-made total contact cast

Locations

Country	Name	City	State
Sweden	Mölndahls sjukhus	Gothenburg
Sweden	Skånes Universitetssjukhus, Malmö	Malmö
Sweden	Örebro Universitetssjukhus	Örebro

Sponsors (3)

Lead Sponsor	Collaborator
Region Örebro County	FORTE, Stiftelsen Promobila

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with healed foot ulcers at 12 weeks	Defined as complete epithelization, verified on a second occasion at least 14 days later. Primary outcome measure is proportion of ulcers healed in each Group after 12 weeks of treatment.	12 weeks after treatment is initiated
Secondary	Number of participants with skin complications through study completion (treatment period, on average 12 weeks)	abrasions, iatrogenic ulcers, blisters, etc.	Through study completion (treatment period, on average 12 weeks)
Secondary	Average level of plasma glucose concentration, measured as glycated haemoglobin (HbA1c)	Blood sample of HbA1c	Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Secondary	Body mass index	weight (kg) divided by squared length (m)	Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Secondary	Gait function assessed with 10 m Walk test, mean value	Time to complete test, longer time is worse	Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Secondary	Gait function assessed with Timed up and go test, mean value	Time to complete test, longer time is worse	Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Secondary	Mean score on Berg balance scale	Total sum score is used, range 0-56 (higher is better)	Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Secondary	Calf muscle atrophy measured as maximal calf circumference	Average values (cm) are reported	Baseline, 1, 6, and 12 months after treatment end
Secondary	General quality of Life measured with Short form 36 (SF-36)	Mean values, score range 0-100 (higher is better)	Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Secondary	General quality of Life measured with Euroqol 5 dimension 5 levels (EQ-5D-5L)	Mean values, score range 0-1 (higher is better)	Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Secondary	Disease-specific quality of life measured with Diabetic foot ulcer scale -short form	Mean values, score range 29-145 (lower is better)	Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Secondary	Mean daily number of steps measured with ActivPAL activity monitor		Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Secondary	Mean daily time spent sitting measured with ActivPAL activity monitor		Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Secondary	Mean daily time spent laying measured with ActivPAL activity monitor		Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Secondary	Mean daily time spent standing measured with ActivPAL activity monitor		Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Secondary	Physical activity measured with the Swedish National Board of Health and Welfare's indicator questions	3 items (intense activity, moderate activity, sitting time), each with 7 response alternatives (higher score is better)	Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Secondary	Bone mass density in heel bone	Dual-energy X-ray absorptiometry (DXA) of calcaneus	Baseline, 1, 6, and 12 months after treatment end
Secondary	Internal locus of control measured with two items from Form C of the Multidimensional Health Locus of Control (MHLC-C) scale	2 items, analyzed separately, score range 1-5 per item (lower is better)	Baseline, approx. 4 weeks into treatment, 1, 6, and 12 months after treatment end
Secondary	Ankle range of motion (dorsal flexion)	goniometer, standardized measurement method	Baseline, 1, 6, and 12 months after treatment end
Secondary	Ankle strength (plantar and dorsal flexion)	dynamometer, standardized measurement method	Baseline, 1, 6, and 12 months after treatment end
Secondary	Adherence to using therapeutic footwear assessed with 2 self-report questions adapted from the Questionnaire for persons with a transfemoral amputation	The 2 questions assess using time: number of days/week (range 0-7) and number of hours/day (6 categories). Higher score is better.	Baseline, 1, 6, and 12 months after treatment end
Secondary	Satisfaction with treatment measured with visual analogue scale	Score range 0-100 (higher is better)	approx. 4 weeks into treatment and 1 month after treatment
Secondary	Number of new foot complications per study group after healing assessed with study-specific questionnaire and patient files	Foot complications include new ulcers, Charcot foot, amputation, etc.	6 and 12 months after treatment end
Secondary	Out-patient health care consumption per participant assessed with study-specific questionnaire and patient files	Study-specific questionnaire with 5 items assessing number of visits (6 response categories, higher is worse) for 5 types of out-patient visits related to the foot ulcer. Patient files will also be used to assess the same variables.	1, 6 and 12 months after treatment end
Secondary	In-patient health care consumption per participant assessed with study-specific questionnaire and patient files	Study-specific questionnaire where participants fill in each hospital admission (and time period) related to the foot ulcer. Also patient files will be used to assess the same variables.	1, 6 and 12 months after treatment end
Secondary	Sick-leave from work (number of days per participant) during treatment period (average 12 weeks) and during the period after treatment end up to 12 months later, assessed with study-specific questionnaire and Swedish Social Insurance Agency's system data	Data from self-report questionnaire and Swedish Social Insurance Agency's system to assess number of days on sick leave	1, 6 and 12 months after treatment end